(136 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement technology and data storage/transmission features, with no mention of AI or ML.
No.
The device is intended for measurement and monitoring of blood pressure and pulse rate, not for treating or preventing a disease or condition.
Yes
The device measures systolic blood pressure, diastolic blood pressure, and pulse rate, which are physiological parameters used to assess and monitor a person's health status. The term "diagnostic device" broadly refers to instruments used to detect, monitor, or assess health conditions. While this device doesn't diagnose a specific disease, the act of measuring and displaying these vital signs falls under the umbrella of diagnostic monitoring because these measurements contribute to understanding a patient's physiological state and can indicate deviations from normal health.
No
The device description explicitly states it is a "battery driven automatic non-invasive blood pressure monitor" and mentions components like an "inflatable CUFF" and "low voltage indication," indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure blood pressure and pulse rate using a non-invasive oscillometric technique on the upper arm. This is a physiological measurement taken directly from the body, not a test performed on a sample of biological material (like blood, urine, or tissue) outside of the body.
- Device Description: The description reinforces the non-invasive nature of the device, using a cuff wrapped around the arm. It measures physical parameters (blood pressure and pulse rate).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or performing tests on materials taken from the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This blood pressure monitor does not fit that definition.
N/A
Intended Use / Indications for Use
The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm at medical facilities or at home.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
AOJ-30 series Arm blood pressure monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or kPa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The device also has low voltage indication, which will be triggered when the battery is low. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use. All the models included in this submission follow the similar software, same measurement principle and same specifications. The differences existed between different models included in this submission will not affect the safety and effectiveness of the device. AOJ-30A and AOJ-30B include the Bluetooth transmission functionality which can transfer data for Application in the external instruments, and the measuring data, including systolic diastolic pressures and pulse rate can be displayed, stored and reviewed by the Application in the external instruments without any control feature, therefore, no interoperability happened. This function is not available for other models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arm
Indicated Patient Age Range
Adult
Intended User / Care Setting
medical facilities or at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data:
Biocompatibility testing: Conducted in accordance with ISO 10993-1. Included Cytotoxicity, Skin Sensitization, and Skin Irritation tests.
Electrical safety and electromagnetic compatibility (EMC) testing: Complies with IEC 60601-1, IEC 60601-1-11, and IEC 60601-1-2.
Bench Testing: Complies with ISO 80601-2-30.
Software Verification and Validation Testing: Conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "major" level of concern.
Clinical data:
Study Type: Clinical validation as per IEC 81060-2: 2013 and ISO 81060-2:2018.
Method: Same Arm Sequential Method.
Sample Size: 100 subjects were involved for each study (for upgraded AOJ-30A, AOJ-30D, and AOJ-30E separately).
Key results: Clinical validation data on the three models (upgraded AOJ-30A, AOJ-30C, AOJ-30D and AOJ-30E) can cover all models included in the submission. Detailed information about Subject number, Gender distribution, Limb size distribution, Blood pressure distribution, Subject preparation, Observer preparation, Reference determination, Clinical investigation methods and Data analysis are referred to ISO 81060-2: 2018 without any deviation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Blood pressure measurement accuracy: ± 3 mmHg
Heart rate measurement accuracy: ± 5% of reading
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
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December 1, 2022
Shenzhen AOJ Medical Technology Co., Ltd. Jack Wang Deputy Chief Room 301&4F, Blk A, Building A, Jingfa IM Park Xiaweiyuan, Gushu Community, Xixiang, Baoan Shenzhen, Guangdong 518126 China
Re: K222125
Trade/Device Name: Arm Blood Pressure Monitor. models AOJ-30A. AOJ-30B. AOJ-30D. AOJ-30E, AOJ-30F and AOJ-30G Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: October 25, 2022 Received: October 31, 2022
Dear Jack Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222125
Device Name
Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30C, AOJ-30C, AOJ-30E, AOJ-30F and AOJ-30G
Indications for Use (Describe)
The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm at medical facilities or at home.
| Type of Use (Select one or both, as applicable) | |
|---|---|
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Shenzhen AOJ Medical Technology Co., Ltd.
Room 301&4F, Block A, Building A,
Jingfa Intelligent Manufacturing Park, Xiaweiyuan, Gushu Community, Xixiang
Street, Bao'an District, 518126, Shenzhen, China
TEL: 86 755-27786026 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jack Wang |
| Prepare date: | October 18, 2022 |
| 2. Device name and
classification: | Device Name: Arm Blood Pressure Monitor
Models: AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and
AOJ-30G
Regulation No.: 21 CFR 870.1130
Review Panel: Cardiovascular
Classification Name: Cardiovascular Diagnostic Devices
Product code: DXN
Regulatory Class: Class II |
| 3. Reason for
Submission: | Change to the previous cleared device AOJ-30A and AOJ-30B, and new application
of AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G without previous
submission. |
| 3. Class III device
statement | Not applicable, the subject device is a non-IVD Class II medical device. |
| 4. Predicate Devices: | Shenzhen AOJ Medical Technology Co., Ltd., AOJ-30B Electronic Blood Pressure
Monitor cleared under K191180. |
| 5. Device Description: | The predicate has not been subject to any recall before.
AOJ-30 series Arm blood pressure monitor is designed as a battery driven automatic
non-invasive blood pressure monitor. It can automatically complete the inflation,
deflation and measurement, which can measure systolic and diastolic blood pressure
as well as the pulse rate of adult person at upper arm within its claimed range and
accuracy via the oscillometric technique. The result will be displayed in the
international unit mmHg or kPa. |
| | The device has the data storage function in order for data reviewing, including the
systolic pressure, diastolic pressure, pulse rate and measurement time. The device
also has low voltage indication, which will be triggered when the battery is low. |
| | The proposed device is intended to be used in medical facilities or at home. And the
effectiveness of this sphygmomanometer has not been established in pregnant
(including pre-eclamptic) patients. |
| | The product is provided non-sterile, and not to be sterilized by the user prior to use. |
| | All the models included in this submission follow the similar software, same
measurement principle and same specifications. The differences existed between
different models included in this submission will not affect the safety and
effectiveness of the device. |
4
K222125
AOJ-30A and AOJ-30B include the Bluetooth transmission functionality which can transfer data for Application in the external instruments, and the measuring data, including systolic diastolic pressures and pulse rate can be displayed, stored and reviewed by the Application in the external instruments without any control feature, therefore, no interoperability happened. This function is not available for other models. The Arm Blood Pressure Monitor is intended to measure the systolic and diastolic 6. Indications for blood pressure, as well as the pulse rate of adult person via non-invasive Use: oscillometric technique in which an inflatable CUFF is wrapped around the upper arm at medical facilities or at home.
7. Predicate Device Comparison
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate devices.
Please refer to following table to find differences between the subject device and predicate device. All the differences do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.
| ITEM | Proposed Device
AOJ-30 series | Predicate Device
AOJ-30B/K191180 | Comparison
Result |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacturer | Shenzhen AOJ Medical
Technology Co., Ltd. | Shenzhen AOJ Medical
Technology Co., Ltd. | Same |
| Intended
Use/Indications for
Use | The Arm Blood Pressure
Monitor is intended to measure
the systolic and diastolic blood
pressure as well as the pulse rate
of adult person via non-invasive
oscillometric technique in which
an inflatable CUFF is wrapped
around the upper arm at medical
facilities or at home. | The Electronic Blood Pressure
Monitor is intended to measure
the systolic and diastolic blood
pressure as well as the pulse rate
of adult person via non-invasive
oscillometric technique in which
an inflatable CUFF is wrapped
around the upper arm at medical
facilities or at home. | Same |
| Contraindications | Not Known | Not Known | Same |
| Application scenario | Medical Facilities and Home
Use | Medical Facilities and Home
Use | Same |
| Operational Specifications | | | |
| Principle | Oscillometric | Oscillometric | Same |
| Measurement Item | SYS, DYS, Pulse Rate | SYS, DYS, Pulse Rate | Same |
| Patient population | Adult | Adult | Same |
| Measurement site | Upper arm | Upper arm | Same |
| Blood pressure
measurement range | 30-255 mmHg | 30 - 255 mmHg | Same |
| Accuracy | $\pm$ 3 mmHg | $\pm$ 3 mmHg | Same |
| Heart rate
measurement range | 40-199 bpm | 40-199 bpm | Same |
| Accuracy | $\pm$ 5% of reading | $\pm$ 5% of reading | Same |
| Cuff size | 22 ~ 42 cm | 2236 cm | Different | 40°C
| Display | Blood Pressure (Systolic and
Diastolic), Pulse rate, Date | Blood Pressure (Systolic and
Diastolic), Pulse rate, Date | Same |
| | Time, WHO BP Classification
Indicating Bar, Low Battery
Icon, Heart Icon, Memory
Record Number | Time, WHO BP Classification
Indicating Bar, Low Battery
Icon, Heart Icon, Memory
Record Number | |
| Auto shutdown | YES | YES | Same |
| Operating
environment | Temperature: 5°C
Humidity: 15%-90% RH,
Atmospheric pressure:
70 kPa - 106 kPa | Temperature: 5°C~ 40°C
Humidity: 15%-90% RH,
Atmospheric pressure:
70 kPa - 106 kPa | Same |
| Storage environment | Ambient Temperature:
-20°C to 55°C
Relative Humidity: 10-93% RH,
Atmospheric pressure:
70 kPa - 106 kPa | Ambient Temperature:
-20°C to 55°C
Relative Humidity: 10-93% RH,
Atmospheric pressure:
70 kPa - 106 kPa | Same |
| Battery type | 6Vdc (4 *1.5V AAA batteries) | 6Vdc (4 *1.5V AAA batteries) | Same |
| Weight | AOJ-30A/AOJ-30B/ AOJ-30G:
(262±5) g without battery
AOJ-30C: (316±5) g without
battery
AOJ-30D: (349±5) g without
battery
AOJ-30E: About 220 g without
battery
AOJ-30F: About 220 g without
battery | Approx. 483.8 g without battery | Different |
| Dimensions | AOJ-30A/AOJ-30B/ AOJ-30G:
127 mm * 93 mm * 73 mm
AOJ-30C:
108 mm * 139 mm * 62 mm
AOJ-30D:
136 mm * 113 mm * 68 mm
AOJ-30E/AOJ-30F:
118 mm * 98 mm * 61mm | 138 mm * 120 mm * 59 mm | |
| Patient Contacting | Surface-contacting,
Less than 24 h | Surface-contacting,
Less than 24 h | Same |
| Biocompatibility
evaluation | Cytotoxicity, skin sensitization
and irritation | Cytotoxicity, skin sensitization
and irritation | Same |
| Electrical safety | IEC 60601-1
IEC 60601-1-11
ISO 80601-2-30 | IEC 60601-1
IEC 60601-1-11
ISO 80601-2-30 | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Biocompatibility | ISO 10993-1
ISO 10993-5
ISO 10993-10 | ISO 10993-1
ISO 10993-5
ISO 10993-10 | Same |
| Data
transmission | Has wireless function with
Bluetooth and available for
AOJ-30A and AOJ-30B only | Not available | Different |
Table 1 Comparison between predicate AOJ-30B and the subject device
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As seen in the comparison tables, the subject and predicate devices have almost the similar design features and performance specifications. As demonstrated in the bench testing, the different technological characteristics do not affect the safety and effectiveness of the subject device.
6
8. Performance Testing:
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
Non-Clinical Data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the device were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests:
- Cytotoxicity
- Skin Sensitization
- Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the device complies with the IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety, IEC 60601-1-11 MEDICAL ELECTRICAL EQUIPMENT –Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, and the IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC.
Bench Testing
Bench testing was conducted on the device, consisting of all the accessories in the system. The system complies with the ISO 80601-2-30 Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers for performance effectiveness.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Clinical data:
The clinical testing has been conducted per IEC 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type on the upgraded AOJ-30A, AOJ-30D and AOJ-30E, and the clinical validation data on the three models can cover all the models included in this submission.
Summary
Regarding the clinical validation required in clause 201.106 Clinical accuracy of IEC 80601-2-30. it has been validated per ISO 81060-2:2018. The Same Arm Sequential Method was chosen and performed on the upgraded AOJ-30A, AOJ-30C, AOJ-30D and AOJ-30E sperately, 100 subjects were involved for each study. Detailed information about the Subject number, Gender distribution, Limb size distribution, Blood pressure distribution, Subject preparation, Observer preparation, Reference determination, Clinical investigation methods and Data analysis are referred to ISO 81060-2: 2018 without any deviation.
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9. Conclusion:
Verification and validation testing was conducted on the subject device and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the AOJ-30 series Arm Blood Pressure Monitor is substantially equivalent to the predicate devices.